Gene therapy trials receive £10m from Government
As part of a £50m commitment to genetics services in the UK, gene therapy trials for muscular dystrophy, childhood blindness and haemophilia are to be financed from a new £4m fund allocated by the Department of Health for 2003–06.
The biggest grant — of £1.6m — will go to the Muscular
Dystrophy Campaign for research at Imperial College, London, aimed at
reducing the severity of the disease to a milder form, so that quality
and length of life is improved for patients. A further £900,000
will go to the Institutes of Ophthalmology and Child Health, London,
for research into inherited retinal disease, and £500,000 will
go to Oxford BioMedica for research into haemophilia A.
A grant of £450,000 has also been made for research into the safety
of retroviral vectors. This follows concerns over two cases of leukaemia
linked to retroviral gene therapy for X-linked Severe Combined Immuno-deficiency
Syndrome (X-SCID) reported in a French trial in 2002. No similar problems
have emerged from comparable trials of retroviral gene therapy
in immune disorders at Great Ormond Street Hospital, London, and three
new patients have joined the studies this year. But all new patients
put forward for the trials are now assessed on a case-by-case basis by
the Gene Therapy Advisory Committee (GTAC) which oversees gene therapy
research in the UK.
In its 10th annual report, published last week, GTAC reported that 13
new gene therapy trials were approved in 2003 — twice the number
agreed in 2002. This brings the total number of gene therapy trials approved
in the UK to 90 since the first study in 1993. Most approved studies
(70 per cent) have been for cancer treatment.
“
The large number of applications in 2003 suggests that the UK continues
to encourage and facilitate gene therapy research within a carefully
balanced regulatory framework, ensuring that the UK maintains its lead
position in Europe for such work,” the report states.
Genetic data system A new genetic data system launched in the US
by the National Institutes of Health and the Food and Drug Administration
is expected to speed up adverse event reporting in human gene therapy
trials. The web-based genetic modification clinical research information
system (GeMCRIS) will include an electronic reporting tool for researchers
to submit adverse event information. At a broader public level it
will enable patients to find out where gene therapy trials are taking
place and which diseases are being studied.
|
|
The
Pharmaceutical Journal
Acrobat
Reader